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The Food and Drug Administration (FDA) announced Friday it has approved the expanded use of the cervical cancer drug, Gardasil, in males ages 9 through 26.

The drug is thought to be effective to fight the human papillomavirus (HPV) types 6 and 11 that cause genital warts.

The FDA on the same day announced it has approved GlaxoSmithKline’s (GSK) HPV vaccine, Cervarix, for girls ages 10 to 25. It is thought to prevent HPV types 16 and 18 that cause the majority of cervical cancers.

The two approvals come just over a month after the FDA considered and an advisory committee recommended the new indication and new product.

Gardasil in Men and Boys

About two out of 1,000 men are diagnosed with genital warts every year, reports the FDA.

Merck, maker of Gardasil, submitted efficacy data from a randomized trial of more than 4,000 men ages 16 to 26 that found in men, not infected by HPV types 6 and 11, that Gardasil was nearly 90 percent effective in preventing genital warts.

Merck must still conduct post-marketing studies on the effectiveness and safety of Gardasil in boys and men, especially high-risk population such as men who have sex with men.

Committee member Pablo Sanchez, a professor of pediatrics at the University of Texas Southwestern Medical Center at Dallas told Hemonctoday.com that “We need studies that examine the long-term immunogenicity, which will in turn provide guidance on whether or not future boosters will be needed.”

While another committee member, Vicky Debold, PhD, RN said more data on safety is needed. She points to a study in the Journal of American Medical Association that suggests an increased risk of fainting and developing blood clots in girls she feels needed more examination before the drug was recommended in males.

Cervarix in Girls, Women

Gardasil (Merck) is already approved for use in girls ages 9 through 26 for the prevention of two types of HPV that cause 75 percent of cervical cancers (strains 16 and 18) and two types of HPV that cause genital warts .

Merck has been urging the expanded use of Gardasil as sales have been somewhat disappointing, and rival, GSK, announced Friday the FDA has approved its cervical cancer vaccine, Cervarix. Sales are expected in the U.S. later this year.

Data submitted by GSK on Cervarix came from the PATRICIA trial published earlier in 2009. GSK says the trial shows the vaccine is 93 percent effective against the virus associated with HPV types 16 and 18 in women who tested seronegative at baseline and DNA negative at six months.

Cervarix contains the adjuvant AS04, containing aluminum hydroxide and monophosphoryl lipid A, reports the FDA, which are not tested for safety. An adjuvant is added to a vaccine to increase the immune response.

Both vaccines are given in a three-shot series over six months with headache, fever, and pain at the injection site as a common reaction.

Britain monitors adverse health events associated with Cervarix, but the recent death of a 14-year old schoolgirl within hours of receiving Cervarix is not included because health officials say she had an underlying tumor, raising questions whether the outwardly appearing healthy girl was about to expire regardless of the “jab” as they are called in the UK.

In the U.S. consumers can search the HPV Vaccine Adverse Event Reporting System (VAERS) which reports as of September 2009 there were more than 15,000 adverse reactions, 7% reported to be serious including Guillain-Barre Syndrome ( GBS), blood clots, and deaths (44).

The FDA denied recommending expanded use of Gardasil in older woman as it is thought to be less effective in people already sexually active.

HPV is the most common sexually transmitted disease in the U.S. and approximately 80 percent of adults are exposed, thought primarily the body’s own immune system takes care of it.

Last year, nearly 4,000 women died of cervical cancer in the U.S. Gardasil users are still encouraged to have a yearly Pap test for cervical cancer. #

2 Comments

Posted by Shawn G, PhDMonday, October 19, 2009 12:16 PM EST

Cervarix uses a relatively new adjuvant which consists of a bacterial endotoxin derivative, called monophosphoryl lipid A, which stimulates a vigorous immune response to the vaccine with the hope that lasting protection is rendered against HPV.

However, we may want to pay close attention to the effects of this adjuvant since it may reach beyond its intended purpose as a mere vaccine enhancing agent. Pre-clinical studies have shown that antibodies can be generated against monophosphoryl lipid A which, in turn, may cross react with other lipids and sterols found within our body.

Based on past publications, it would be reasonable to assume that GSK and the FDA have already asked whether anti-lipid antibodies are generated in their clinical trial patients. If so, what are the effects of elevated anti-lipid antibodies?

So, prior to vaccination with Cervarix -- and other GSK vaccines that use monophosphoryl lipid A as the adjuvant -- it may be prudent to ask what anti-lipid or anti-sterol antibodies are elevated, if any. And if not yet tested, why not?

There are many questions to be asked before we do a mass vaccinating of our young girls. The CDC is meeting with an advisory group on vaccines Wednesday and there will be protestors there seeking more full disclosure.

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